MAUDE Adverse Event Report: LIVANOVA DEUTSCHLAND ELECTRONIC GAS BLENDER; GAS CONTROL UNIT, CARDIOPULMONARY BYPASS

Model Number	S5 COMPONENT GAS BLENDER
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/06/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A.1.- a.5.Patient information was not provided.H11: livanova deutschland manufactures the electronic gas blender (egb) referenced in this report.The event occurred in (b)(6) austria.Livanova has initiated an investigation into the reported issue.
Event or Problem Description
Livanova deutschland has received a report concerning an electronic gas blender (egb) delivering a flow rate that differed from the value shown on the device display.The customer indicated that no error codes were generated; only the delivered flow did not correspond to the displayed flow rate.The issue was reportedly observed during a procedure.No patient impact occurred.

• Brand Name: ELECTRONIC GAS BLENDER
• Common Device Name: GAS CONTROL UNIT, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): LIVANOVA DEUTSCHLAND; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer (Section G): LIVANOVA DEUTSCHLAND GMBH; lindberghstrasse 25; munich 80939 ; GM 80939
• Manufacturer Contact: annarita di lascio ; 14401 w. 65th way; arvada, CO 80004
• MDR Report Key: 24555871
• Report Number: 9611109-2026-90080
• Device Sequence Number: 8860461
• Product Code: DTX
• UDI-Device Identifier: 04033817900696
• UDI-Public: (01)04033817900696(11)231006
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K101046
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: S5 COMPONENT GAS BLENDER
• Device Catalogue Number: 25-40-45
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/10/2026
• Supplement Date Received by Manufacturer: 05/15/2026
• Initial Report FDA Received Date: 03/10/2026
• Supplement Report FDA Received Date: 06/12/2026
• Date Device Manufactured: 10/06/2023
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown